LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy (LAPLACE)

November 10, 2022 updated by: Amgen

LAPLACE TIMI 57 - A Double-blind, Randomized, Placebo-controlled, Multicenter, Dose-ranging Study to Evaluate Tolerability and Efficacy of AMG 145 on LDL-C in Combination With HMG-CoA Reductase Inhibitors in Hypercholesterolemic Subjects

To evaluate the effect of 12 weeks of subcutaneous (SC) evolocumab (AMG 145) administered every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on percent change from baseline in LDL-C when used in addition to a statin in adults with hypercholesterolemia.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
631

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4M6
        • Research Site
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 1T4
        • Research Site
      • Kelowna, British Columbia, Canada, V1Y 1V6
        • Research Site
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Research Site
      • Victoria, British Columbia, Canada, V8T 5G1
        • Research Site
    • Ontario
      • Cambridge, Ontario, Canada, N1R 6V6
        • Research Site
      • Hamilton, Ontario, Canada, L8L 2X2
        • Research Site
      • London, Ontario, Canada, N5W 6A2
        • Research Site
      • London, Ontario, Canada, N6A 5K8
        • Research Site
      • Newmarket, Ontario, Canada, L3Y 5G8
        • Research Site
      • Oshawa, Ontario, Canada, L1J 2K1
        • Research Site
      • Oshawa, Ontario, Canada, L1J 2J9
        • Research Site
      • Sarnia, Ontario, Canada, N7T 4X3
        • Research Site
      • Scarborough, Ontario, Canada, M1P 2T7
        • Research Site
      • Sudbury, Ontario, Canada, P3C 5K7
        • Research Site
      • Toronto, Ontario, Canada, M9V 4B4
        • Research Site
      • Toronto, Ontario, Canada, M8V 3X8
        • Research Site
      • Woodstock, Ontario, Canada, N4S 5P5
        • Research Site
    • Quebec
      • Gatineau, Quebec, Canada, J8Y 6S9
        • Research Site
      • Lachine, Quebec, Canada, H8S 2E4
        • Research Site
      • Longueuil, Quebec, Canada, J4N 0C9
        • Research Site
      • Pointe-Claire, Quebec, Canada, H9R 3J1
        • Research Site
  • Czechia
      • Brno, Czechia, 625 00
        • Research Site
      • Brno, Czechia, 656 91
        • Research Site
      • Brno, Czechia, 603 00
        • Research Site
      • Olomouc, Czechia, 775 20
        • Research Site
      • Praha 2, Czechia, 120 00
        • Research Site
      • Praha 4, Czechia, 140 21
        • Research Site
      • Slany, Czechia, 274 01
        • Research Site
      • Svitavy, Czechia, 568 25
        • Research Site
      • Usti nad Orlici, Czechia, 562 18
        • Research Site
      • Znojmo, Czechia, 669 02
        • Research Site
  • Denmark
      • Aalborg, Denmark, 9000
        • Research Site
      • Ballerup, Denmark, 2750
        • Research Site
      • Vejle, Denmark, 7100
        • Research Site
  • Hungary
      • Budapest, Hungary, 1096
        • Research Site
      • Debrecen, Hungary, 4032
        • Research Site
      • Dunaujvaros, Hungary, 2400
        • Research Site
      • Eger, Hungary, 3300
        • Research Site
      • Gyula, Hungary, 5700
        • Research Site
      • Kecskemet, Hungary, 6000
        • Research Site
      • Komarom, Hungary, 2991
        • Research Site
      • Mosonmagyarovar, Hungary, 9200
        • Research Site
      • Szolnok, Hungary, 5004
        • Research Site
      • Zalaegerszeg, Hungary, 8900
        • Research Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Research Site
    • Arizona
      • Tucson, Arizona, United States, 85710
        • Research Site
    • Arkansas
      • Malvern, Arkansas, United States, 72104
        • Research Site
    • California
      • Anaheim, California, United States, 92801
        • Research Site
      • Carmichael, California, United States, 95608
        • Research Site
      • Newport Beach, California, United States, 92663
        • Research Site
      • Roseville, California, United States, 95747
        • Research Site
      • Westlake Village, California, United States, 91361
        • Research Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Research Site
      • Littleton, Colorado, United States, 80120
        • Research Site
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Research Site
      • Green Cove Springs, Florida, United States, 32043
        • Research Site
      • Melbourne, Florida, United States, 32901
        • Research Site
      • Miami, Florida, United States, 33173
        • Research Site
      • Miami, Florida, United States, 33143
        • Research Site
      • Port Charlotte, Florida, United States, 33952
        • Research Site
    • Illinois
      • Peoria, Illinois, United States, 61614
        • Research Site
    • Indiana
      • Hammond, Indiana, United States, 46320
        • Research Site
      • Indianapolis, Indiana, United States, 46237
        • Research Site
      • Valparaiso, Indiana, United States, 46383
        • Research Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Research Site
    • Maine
      • Auburn, Maine, United States, 04210
        • Research Site
      • Bangor, Maine, United States, 04401
        • Research Site
      • Portland, Maine, United States, 04101
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Research Site
      • Marquette, Michigan, United States, 49855
        • Research Site
      • Ypsilanti, Michigan, United States, 48197
        • Research Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Research Site
    • Montana
      • Great Falls, Montana, United States, 59405
        • Research Site
    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Research Site
    • New York
      • Cortlandt Manor, New York, United States, 10567
        • Research Site
      • Williamsville, New York, United States, 14221
        • Research Site
    • North Carolina
      • Smithfield, North Carolina, United States, 27577
        • Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Research Site
    • Ohio
      • Canton, Ohio, United States, 44708
        • Research Site
      • Cincinnati, Ohio, United States, 45219
        • Research Site
      • Cincinnati, Ohio, United States, 45212
        • Research Site
      • Dayton, Ohio, United States, 45414
        • Research Site
      • Mansfield, Ohio, United States, 44906
        • Research Site
      • Marion, Ohio, United States, 43302
        • Research Site
      • Sandusky, Ohio, United States, 44870
        • Research Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Research Site
      • Pittsburgh, Pennsylvania, United States, 15216
        • Research Site
      • York, Pennsylvania, United States, 17405
        • Research Site
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Research Site
      • Spartanburg, South Carolina, United States, 29302
        • Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Research Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Research Site
      • Jackson, Tennessee, United States, 38301
        • Research Site
    • Texas
      • Houston, Texas, United States, 77074
        • Research Site
      • Houston, Texas, United States, 77002
        • Research Site
    • Washington
      • Tacoma, Washington, United States, 98405
        • Research Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53713
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female ≥ 18 to ≤ 80 years of age
  • On an approved statin, with or without ezetimibe, with stable dose(s) for at least 4 weeks
  • Fasting LDL-C ≥ 85 mg/dL
  • Fasting triglycerides ≤ 400 mg/dL

Exclusion Criteria:

  • Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization
  • Type 1 diabetes; newly diagnosed or poorly controlled type 2 diabetes (Glycosyated Hemoglobin (HbA1c) > 8.5%)
  • Uncontrolled hypertension
  • New York Heart Association (NYHA) III or IV heart failure, or known left ventricular ejection fraction < 30%
  • Uncontrolled cardiac arrhythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo Q2W
Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
Other: Placebo to Evolocumab
Administered by subcutaneous injection
PLACEBO_COMPARATOR: Placebo Q4W
Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
Other: Placebo to Evolocumab
Administered by subcutaneous injection
EXPERIMENTAL: Evolocumab 70 mg Q2W
Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
EXPERIMENTAL: Evolocumab 105 mg Q2W
Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
EXPERIMENTAL: Evolocumab 140 mg Q2W
Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
EXPERIMENTAL: Evolocumab 280 mg Q4W
Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
EXPERIMENTAL: Evolocumab 350 mg Q4W
Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145
EXPERIMENTAL: Evolocumab 420 mg Q4W
Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Biological: Evolocumab
Administered by subcutaneous injection
Other Names:
  • Repatha
  • AMG 145

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
Time Frame: Baseline and Week 12
LDL-C was measured using ultracentrifugation.
Baseline and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Apolipoprotein B at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Change From Baseline in LDL-C at Week 12
Time Frame: Baseline and Week 12
LDL-C was measured using ultracentrifugation.
Baseline and Week 12
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Total Cholesterol/HDL-C Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12
Percent Change From Baseline in Apolipoprotein B/Apolipoprotein A-1 Ratio at Week 12
Time Frame: Baseline and Week 12
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
TIMI Study Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 5, 2012

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 5, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2011

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2011

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20101155

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings